Routine Antenatal Care Versus Screening and Treatment of Malaria in Pregnancy in Rwanda

• ClinicalTrials.gov Identifier: NCT03508349
• Recruitment Status: Completed
• First Posted: April 25, 2018
• Last Update Posted: December 6, 2019
• Sponsor: Jhpiego
• Collaborators: Rwanda Malaria and Other Parasitic Diseases Division (MOPDD); Centers for Disease Control and Prevention
• Information provided by (Responsible Party): Jhpiego

Study Description

Brief Summary:

The main aim of this study is to test the primary hypothesis that the addition of intermittent screening and treatment of malaria in pregnant women (ISTp) who receive routine antenatal care (ANC) in health facilities in high malaria transmission areas in Rwanda will reduce malaria prevalence among pregnant women when compared to routine antenatal cares services alone.

Condition or disease	Intervention/treatment	Phase
Malaria in Pregnancy	Diagnostic Test: IST	Not Applicable

Detailed Description:

More specifically, the primary objective is to understand the effect of ISTp in a context where routine antenatal care does not include malaria chemoprohylaxis and whether this intervention is protective against malaria during pregnancy. The secondary objective is to determine whether this intervention results in an improvement in other key maternal and newborn health outcomes including maternal anemia, low birth weight and prematurity. The third objective is to determine the feasibility, effectiveness and acceptability of ISTp among women who receive ISTp and among health workers who deliver this intervention.

This study will establish if testing and treating pregnant women is effective, feasible and whether it adds an additional burden to the work already being undertaken by facility-based health workers who provide antenatal care services. It is expected that the study will result in information to develop appropriate approaches that can be implemented in Rwanda in the prevention of malaria in pregnancy in addition to the use of preventive measures such as insecticide treated mosquito nets (ITNs) and case management. This information may potentially also be used by other countries with similar patterns of malaria transmission.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1786 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Health facilities in high malaria transmission zones were pair matched and then randomized to be an intervention or a control facility.
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Effectiveness of Intermittent Screening and Treatment of Malaria in Pregnancy (ISTp) on Maternal and Birth Outcomes in Selected Districts in Rwanda
• Actual Study Start Date: September 5, 2016
• Actual Primary Completion Date: October 31, 2018
• Actual Study Completion Date: March 18, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: IST using RDT; Women presenting for their first ANC visit to facilities will be consecutively enrolled after providing informed consent. Women in the intervention group (IST+ routine care) will be tested for malaria at the health center during their ANC visits with an RDT. If positive, they will be treated with artemisinin-based combination therapy (ACT) in second or third trimester or quinine in the first trimester.	Diagnostic Test: IST; Women in the control group will receive routine care, which does not include testing for malaria with a rapid diagnostic test unless symptomatic for malaria. Women in the intervention group will receive this additional testing for malaria at each antenatal care, regardless of whether she is symptomatic for malaria.
No Intervention: Routine Antenatal Care; Women presenting for their first ANC visit to facilities will be consecutively enrolled after providing informed consent. Women in the comparison group (routine care) will receive routine antenatal care services per the national guidelines. They will not be tested for malaria at each antenatal care visit unless they are symptomatic for malaria.

Outcome Measures

Primary Outcome Measures :

1. Prevalence of placental malaria at delivery (tested by PCR) [ Time Frame: at the time of delivery ]
   comparison of prevalence of malaria between women in intervention and control sites

Secondary Outcome Measures :

1. Prevalence of maternal anemia at delivery [ Time Frame: at the time of delivery ]
   comparison of prevalence of maternal anemia between women in intervention and control sites
2. Prevalence of low birth weight babies (<37 weeks gestation) [ Time Frame: at the time of delivery ]
   comparison of prevalence of LBW between women in intervention and control sites
3. Prevalence of preterm births [ Time Frame: at the time of delivery ]
   comparison of prevalence of preterm births between women in intervention and control sites
4. Episodes of clinical malaria during the course of the pregnancy [ Time Frame: assessed at the time of delivery ]
   description of the number of episodes of malaria detected during antenatal care visits during pregnancy

Other Outcome Measures:

1. Adverse outcome of pregnancy - abortions, still births and neonatal deaths [ Time Frame: assessed at the time of delivery ]
   Description of the number of adverse outcomes by group

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 49 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: pregnant at the time of enrollment in the study
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Pregnant women age 18 or older who have their first ANC visit during the study recruitment period
• Willing to participate

Exclusion Criteria:

• • Pregnant women below the age of 18

  • Not willing to participate

Contacts and Locations

Locations

Rwanda

Busoro-Gishamvu Health Center

Huye, South, Rwanda

Huye Police Health Center

Huye, South, Rwanda

Maraba Health Cente

Huye, South, Rwanda

Mukura Health Center

Huye, South, Rwanda

Rango Health Center

Huye, South, Rwanda

Rubona Health Center

Huye, South, Rwanda

Rwaniro

Huye, South, Rwanda

Sovu Health Center

Huye, South, Rwanda

Kamonyi Health Center

Kamonyi, South, Rwanda

Kayenzi Health Center

Kamonyi, South, Rwanda

Mugina Health Center

Kamonyi, South, Rwanda

Musambira Health Center

Kamonyi, South, Rwanda

Nyagihamba Health Center

Kamonyi, South, Rwanda

Nyamiyaga Health Center

Kamonyi, South, Rwanda

Sponsors and Collaborators

Jhpiego

Rwanda Malaria and Other Parasitic Diseases Division (MOPDD)

Centers for Disease Control and Prevention

Investigators

• Principal Investigator: Reena Sethi, DrPH; Jhpiego

More Information

• Responsible Party: Jhpiego
• ClinicalTrials.gov Identifier: NCT03508349
• Other Study ID Numbers: 6829
• First Posted: April 25, 2018
• Last Update Posted: December 6, 2019
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases